GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
Purpose
This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection
Conditions
- Pneumonitis
- SARS-CoV Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 18 years or older - Able to provide consent - Able and willing to comply with study procedures - Diagnosis of PCR confirmed SARS-CoV-2 - Enrollment within 72 of hospitalization - WHO COVID-19 classification level 3 or 4
Exclusion Criteria
- Pregnant or lactating - Need for mechanical ventilation, non-invasive ventilation (NIV), or high-flow O2 (≥60%) via face mask - Calculated GFR < 60 (Cockcroft-Gault) - Meets treatment algorithm criteria for treatment with a non-study immune modulator - Pre-study or planned treatment with a non-study immune modulator - Participation in a COVID-19 clinical trial that includes prescription of a drug with anti-cytokine activity - Status post transplantation of an organ, bone marrow, or body part - Treatment within the past 60 days with a chemotherapeutic agent - Diagnosis of leukemia or lymphoma - WHO COVID-19 classification level of 5 or greater - Unable to take oral medication - Grade 3 or greater laboratory abnormalities as characterized by CTCAE v5
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental GLS-1027 120 mg |
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily |
|
|
Experimental GLS-1027 360 mg |
Three 120 mg pills of GLS-1027 given by mouth once daily |
|
|
Placebo Comparator Placebo |
Three Placebo pills given by mouth once daily |
|
Recruiting Locations
More Details
- NCT ID
- NCT04590547
- Status
- Active, not recruiting
- Sponsor
- GeneOne Life Science, Inc.
Detailed Description
This Phase II randomized, double-blind, placebo-controlled, study will assess 2 different doses of GLS-1027 in the prevention of severe pneumonitis among those hospitalized with PCR confirmed SARS-CoV-2 infection. Subjects will be randomized at a 1:1:1 ratio to either Standard of Care (SOC) plus placebo, or SOC plus GLS-1027 at either 120 mg or 360 mg daily. Clinical status will be monitored through 56 days from the initiation of treatment.